Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2019 | Oct. 25, 2019 | |
Cover page. | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2019 | |
Document Transition Report | false | |
Entity File Number | 001-36014 | |
Entity Registrant Name | AGIOS PHARMACEUTICALS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 26-0662915 | |
Entity Address, Address Line One | 88 Sidney Street | |
Entity Address, City or Town | Cambridge | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02139 | |
City Area Code | 617 | |
Local Phone Number | 649-8600 | |
Title of 12(b) Security | Common Stock, Par Value $0.001 per share | |
Trading Symbol | AGIO | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 58,883,044 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false | |
Entity Central Index Key | 0001439222 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 81,709 | $ 70,502 |
Marketable securities | 370,188 | 514,800 |
Accounts receivable, net | 7,106 | 5,076 |
Collaboration receivable – related party | 1,838 | 2,462 |
Collaboration receivable – other | 869 | 670 |
Royalty receivable – related party | 2,600 | 2,234 |
Inventory | 5,849 | 869 |
Prepaid expenses and other current assets | 19,985 | 17,167 |
Total current assets | 490,144 | 613,780 |
Marketable securities | 88,579 | 220,119 |
Operating lease assets | 95,833 | |
Property and equipment, net | 24,060 | 24,320 |
Other non-current assets | 0 | 238 |
Total assets | 698,616 | 858,457 |
Current liabilities: | ||
Accounts payable | 21,511 | 17,880 |
Accrued expenses | 46,750 | 42,147 |
Deferred revenue – related party | 16,873 | 32,710 |
Operating lease liabilities | 7,298 | |
Deferred rent | 0 | 766 |
Total current liabilities | 92,432 | 93,503 |
Deferred revenue, net of current portion – related party | 49,797 | 59,809 |
Operating lease liabilities, net of current portion | 108,096 | |
Deferred rent, net of current portion | 0 | 17,608 |
Total liabilities | 250,325 | 170,920 |
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; 25,000,000 shares authorized; no shares issued or outstanding at September 30, 2019 and December 31, 2018 | 0 | 0 |
Common stock, $0.001 par value; 125,000,000 shares authorized; 58,877,691 and 58,218,653 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 59 | 58 |
Additional paid-in capital | 1,861,523 | 1,794,283 |
Accumulated other comprehensive income (loss) | 464 | (2,171) |
Accumulated deficit | (1,413,755) | (1,104,633) |
Total stockholders’ equity | 448,291 | 687,537 |
Total liabilities and stockholders’ equity | $ 698,616 | $ 858,457 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 25,000,000 | 25,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 125,000,000 | 125,000,000 |
Common stock, shares issued (in shares) | 58,877,691 | 58,218,653 |
Common stock, shares outstanding (in shares) | 58,877,691 | 58,218,653 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Revenues: | ||||
Total revenue | $ 26,024 | $ 15,198 | $ 82,472 | $ 64,374 |
Cost and expenses: | ||||
Cost of sales | 393 | 695 | 1,030 | 695 |
Research and development | 101,672 | 82,561 | 304,646 | 247,515 |
Selling, general and administrative | 33,019 | 31,104 | 97,200 | 82,287 |
Total cost and expenses | 135,084 | 114,360 | 402,876 | 330,497 |
Loss from operations | (109,060) | (99,162) | (320,404) | (266,123) |
Interest income | 2,887 | 4,498 | 11,282 | 11,889 |
Net loss | $ (106,173) | $ (94,664) | $ (309,122) | $ (254,234) |
Net loss per share – basic and diluted (in usd per share) | $ (1.81) | $ (1.63) | $ (5.27) | $ (4.45) |
Weighted-average number of common shares used in computing net loss per share – basic and diluted (in usd per share) | 58,803,534 | 58,033,386 | 58,661,607 | 57,158,492 |
Product revenue, net | ||||
Revenues: | ||||
Total revenue | $ 17,422 | $ 4,465 | $ 40,287 | $ 4,465 |
Collaboration revenue – related party | ||||
Revenues: | ||||
Total revenue | 5,516 | 8,732 | 32,414 | 42,478 |
Collaboration revenue – other | ||||
Revenues: | ||||
Total revenue | 420 | 0 | 2,202 | 12,440 |
Royalty revenue – related party | ||||
Revenues: | ||||
Total revenue | $ 2,666 | $ 2,001 | $ 7,569 | $ 4,991 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (106,173) | $ (94,664) | $ (309,122) | $ (254,234) |
Other comprehensive (loss) income | ||||
Unrealized (loss) gain on available-for-sale securities | (26) | 279 | 2,635 | (730) |
Comprehensive loss | $ (106,199) | $ (94,385) | $ (306,487) | $ (254,964) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2017 | 48,826,153 | ||||
Beginning balance at Dec. 31, 2017 | $ 375,503 | $ 49 | $ 1,174,904 | $ (1,389) | $ (798,061) |
Issuance of common stock for follow-on offering (in shares) | 8,152,986 | ||||
Issuance of common stock for follow-on offering | 516,206 | $ 8 | 516,198 | ||
Common stock issued under stock incentive plan and ESPP (in shares) | 562,474 | ||||
Common stock issued under stock incentive plan and ESPP | 12,332 | $ 1 | 12,331 | ||
Stock-based compensation expense | 14,522 | 14,522 | |||
Other comprehensive income (loss) | (1,254) | (1,254) | |||
Net loss | (90,825) | (90,825) | |||
Other | (346) | (346) | |||
Ending balance (in shares) at Mar. 31, 2018 | 57,541,613 | ||||
Ending balance at Mar. 31, 2018 | 865,594 | $ 58 | 1,717,609 | (2,643) | (849,430) |
Beginning balance (in shares) at Dec. 31, 2017 | 48,826,153 | ||||
Beginning balance at Dec. 31, 2017 | 375,503 | $ 49 | 1,174,904 | (1,389) | (798,061) |
Net loss | (254,234) | ||||
Ending balance (in shares) at Sep. 30, 2018 | 58,167,932 | ||||
Ending balance at Sep. 30, 2018 | 760,213 | $ 58 | 1,775,113 | (2,119) | (1,012,839) |
Beginning balance (in shares) at Mar. 31, 2018 | 57,541,613 | ||||
Beginning balance at Mar. 31, 2018 | 865,594 | $ 58 | 1,717,609 | (2,643) | (849,430) |
Common stock issued under stock incentive plan and ESPP (in shares) | 391,423 | ||||
Common stock issued under stock incentive plan and ESPP | 9,638 | 9,638 | |||
Stock-based compensation expense | 16,455 | 16,455 | |||
Other comprehensive income (loss) | 245 | 245 | |||
Net loss | (68,745) | (68,745) | |||
Other | (45) | (45) | |||
Ending balance (in shares) at Jun. 30, 2018 | 57,933,036 | ||||
Ending balance at Jun. 30, 2018 | 823,142 | $ 58 | 1,743,657 | (2,398) | (918,175) |
Common stock issued under stock incentive plan and ESPP (in shares) | 234,896 | ||||
Common stock issued under stock incentive plan and ESPP | 7,263 | 7,263 | |||
Stock-based compensation expense | 24,193 | 24,193 | |||
Other comprehensive income (loss) | 279 | 279 | |||
Net loss | (94,664) | (94,664) | |||
Ending balance (in shares) at Sep. 30, 2018 | 58,167,932 | ||||
Ending balance at Sep. 30, 2018 | 760,213 | $ 58 | 1,775,113 | (2,119) | (1,012,839) |
Beginning balance (in shares) at Dec. 31, 2018 | 58,218,653 | ||||
Beginning balance at Dec. 31, 2018 | 687,537 | $ 58 | 1,794,283 | (2,171) | (1,104,633) |
Common stock issued under stock incentive plan and ESPP (in shares) | 441,168 | ||||
Common stock issued under stock incentive plan and ESPP | 6,003 | $ 1 | 6,002 | ||
Stock-based compensation expense | 18,108 | 18,108 | |||
Other comprehensive income (loss) | 1,687 | 1,687 | |||
Net loss | (93,078) | (93,078) | |||
Ending balance (in shares) at Mar. 31, 2019 | 58,659,821 | ||||
Ending balance at Mar. 31, 2019 | 620,257 | $ 59 | 1,818,393 | (484) | (1,197,711) |
Beginning balance (in shares) at Dec. 31, 2018 | 58,218,653 | ||||
Beginning balance at Dec. 31, 2018 | $ 687,537 | $ 58 | 1,794,283 | (2,171) | (1,104,633) |
Common stock issued under stock incentive plan and ESPP (in shares) | 253,323 | ||||
Net loss | $ (309,122) | ||||
Ending balance (in shares) at Sep. 30, 2019 | 58,877,691 | ||||
Ending balance at Sep. 30, 2019 | 448,291 | $ 59 | 1,861,523 | 464 | (1,413,755) |
Beginning balance (in shares) at Mar. 31, 2019 | 58,659,821 | ||||
Beginning balance at Mar. 31, 2019 | 620,257 | $ 59 | 1,818,393 | (484) | (1,197,711) |
Common stock issued under stock incentive plan and ESPP (in shares) | 89,365 | ||||
Common stock issued under stock incentive plan and ESPP | 2,770 | 2,770 | |||
Stock-based compensation expense | 18,547 | 18,547 | |||
Other comprehensive income (loss) | 974 | 974 | |||
Net loss | (109,871) | (109,871) | |||
Ending balance (in shares) at Jun. 30, 2019 | 58,749,186 | ||||
Ending balance at Jun. 30, 2019 | 532,677 | $ 59 | 1,839,710 | 490 | (1,307,582) |
Common stock issued under stock incentive plan and ESPP (in shares) | 128,505 | ||||
Common stock issued under stock incentive plan and ESPP | 3,225 | 3,225 | |||
Stock-based compensation expense | 18,588 | 18,588 | |||
Other comprehensive income (loss) | (26) | (26) | |||
Net loss | (106,173) | (106,173) | |||
Ending balance (in shares) at Sep. 30, 2019 | 58,877,691 | ||||
Ending balance at Sep. 30, 2019 | $ 448,291 | $ 59 | $ 1,861,523 | $ 464 | $ (1,413,755) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Operating activities | ||
Net loss | $ (309,122) | $ (254,234) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 6,124 | 5,261 |
Stock-based compensation expense | 55,243 | 55,170 |
Net accretion of premium and discounts on investments | (2,772) | (2,540) |
Loss (gain) on disposal of property and equipment | 466 | (20) |
Non-cash operating lease expense | 6,341 | |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (2,030) | (2,631) |
Collaboration receivable – related party | 624 | (947) |
Collaboration receivable – other | (199) | (440) |
Royalty receivable – related party | (366) | (641) |
Inventory | (4,980) | (863) |
Prepaid expenses and other current and non-current assets | (3,552) | 1,711 |
Accounts payable | 2,649 | (5,830) |
Accrued expenses | 4,602 | (8,537) |
Deferred revenue – related party | (25,849) | (15,749) |
Operating lease liabilities | (4,190) | |
Deferred rent | 0 | 56 |
Net cash used in operating activities | (277,011) | (230,234) |
Investing activities | ||
Purchases of marketable securities | (194,822) | (755,368) |
Proceeds from maturities and sales of marketable securities | 476,382 | 500,281 |
Purchases of property and equipment | (5,347) | (5,933) |
Net cash provided by (used in) investing activities | 276,213 | (261,020) |
Financing activities | ||
Payment of public offering costs, net of reimbursements | 0 | (391) |
Proceeds from public offering of common stock, net of commissions | 0 | 516,206 |
Net proceeds from stock option exercises and employee stock purchase plan | 12,005 | 29,193 |
Net cash provided by financing activities | 12,005 | 545,008 |
Net change in cash and cash equivalents | 11,207 | 53,754 |
Cash and cash equivalents at beginning of the period | 70,502 | 102,724 |
Cash and cash equivalents at end of the period | 81,709 | 156,478 |
Supplemental disclosure of non-cash investing and financing transactions | ||
Additions to property and equipment in accounts payable and accrued expenses | 2,089 | 501 |
Proceeds from stock option exercises in other current assets | 0 | $ 39 |
Operating lease liabilities arising from obtaining operating lease assets | $ 42,322 |
Overview and Basis of Presentat
Overview and Basis of Presentation | 9 Months Ended |
Sep. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Overview and Basis of Presentation | Overview and Basis of Presentation References to Agios Throughout this Quarterly Report on Form 10-Q, “we,” “us,” and “our,” and similar expressions, except where the context requires otherwise, refer to Agios Pharmaceuticals, Inc. and its consolidated subsidiaries, and “our Board of Directors” refers to the board of directors of Agios Pharmaceuticals, Inc. Overview We are a biopharmaceutical company committed to the fundamental transformation of patients’ lives through scientific leadership in the field of cellular metabolism and adjacent areas of biology, with the goal of making transformative, first- or best-in-class medicines for the treatment of cancer and rare genetic diseases, or RGDs. To address both cancer and RGDs, we take a systems biology approach to deeply understand disease states, drive the discovery and validation of novel therapeutic targets, and define patient selection strategies, thereby increasing the probability that our experimental medicines will have the desired therapeutic effect. We are located in Cambridge, Massachusetts. Basis of presentation The condensed consolidated balance sheet as of September 30, 2019, the condensed consolidated statements of operations, comprehensive loss and stockholders' equity for the three and nine months ended September 30, 2019 and 2018, and the condensed consolidated statements of cash flows for the nine months ended September 30, 2019 and 2018 are unaudited. The unaudited condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of our management, reflect all adjustments, which include only normal recurring adjustments, necessary to fairly state our financial position as of September 30, 2019, our results of operations and stockholders' equity for the three and nine months ended September 30, 2019 and 2018, and cash flows for the nine months ended September 30, 2019 and 2018. The financial data and the other financial information disclosed in these notes to the condensed consolidated financial statements related to the three and nine-month periods are also unaudited. The results of operations for the three and nine months ended September 30, 2019 are not necessarily indicative of the results to be expected for the year ending December 31, 2019 or for any other future annual or interim period. The condensed consolidated balance sheet data as of December 31, 2018 was derived from our audited financial statements, but does not include all disclosures required by U.S. generally accepted accounting principles, or U.S. GAAP. Accordingly, the condensed consolidated interim financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2018 that was filed with the Securities and Exchange Commission, or the SEC, on February 14, 2019. Our condensed consolidated financial statements include our accounts and the accounts of our wholly owned subsidiaries. All intercompany transactions have been eliminated in consolidation. The condensed consolidated financial statements have been prepared in conformity with U.S. GAAP. Liquidity As of September 30, 2019, we had cash, cash equivalents and marketable securities of $540.5 million. Although we have incurred recurring losses and expect to continue to incur losses for the foreseeable future, we expect our cash, cash equivalents and marketable securities will be sufficient to fund current operations for at least the next twelve months from the issuance date of these financial statements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Leases In February 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2016-02, Leases (Topic 842) , which was codified as Accounting Standards Codification, or ASC, 842, Leases , and amended through subsequent ASUs. We adopted ASC 842 effective January 1, 2019 using the modified retrospective transition approach and elected the package of practical expedients, both provided for under ASU 2018-11, Leases (Topic 842): Targeted Improvements . The package of practical expedients allows us not to reassess whether contracts are or contain leases, lease classification, and whether initial direct costs qualify for capitalization. Additionally, as an accounting policy, we have chosen not to separate the non-lease components from the lease components for our building leases and, instead, accounted for non-lease and lease components as a single component. Impact of Adoption of ASC 842 Upon adoption of ASC 842 on January 1, 2019, we recorded operating lease assets of $59.9 million and operating lease liabilities of $77.3 million. The adoption of ASC 842 did not have a material impact on our condensed consolidated statements of operations. Prior periods are presented in accordance with ASC 840, Leases . Leases Accounting Policy We determine if an arrangement is a lease at inception. An arrangement is determined to contain a lease if the contract conveys the right to control the use of an identified property, plant, or equipment for a period of time in exchange for consideration. If we can benefit from the various underlying assets of a lease on their own or together with other resources that are readily available, or if the various underlying assets are neither highly dependent on nor highly interrelated with other underlying assets in the arrangement, they are considered to be a separate lease component. In the event multiple underlying assets are identified, the lease consideration is allocated to the various components based on each of the component’s relative fair value. Operating lease assets represent our right to use an underlying asset for the lease term and operating lease liabilities represent our obligation to make lease payments arising from the leasing arrangement. Operating lease assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As most of our leases do not provide an implicit rate, in determining the operating lease liabilities we use an estimate of our incremental borrowing rate. The incremental borrowing rate is determined using two alternative credit scoring models to estimate our credit rating, adjusted for collateralization. The calculation of the operating lease assets includes any lease payments made and excludes any lease incentives. Our lease terms may include options to extend or terminate the lease when it is reasonably certain that we will exercise that option. For operating leases, we record operating lease assets and liabilities in our consolidated balance sheets. Lease expense for lease payments is recognized on a straight-line basis over the lease term. Short-term leases, or leases that have a lease term of 12 months or less at commencement date, are excluded from this treatment and are recognized on a straight-line basis over the term of the lease. Recent accounting pronouncements Other accounting standards that have been issued by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on our financial statements upon adoption. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements We record cash equivalents and marketable securities at fair value. ASC 820, Fair Value Measurements and Disclosures , establishes a fair value hierarchy for those instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and our own assumptions (unobservable inputs). The hierarchy consists of three levels: Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities. Level 2 – Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, directly or indirectly, for substantially the full term of the asset or liability. Level 3 – Unobservable inputs that reflect our own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date. The following table summarizes our cash equivalents and marketable securities measured at fair value on a recurring basis as of September 30, 2019 (in thousands): Level 1 Level 2 Level 3 Total Cash equivalents $ 14,172 $ 21,444 $ — $ 35,616 Marketable securities: U.S. Treasuries — 161,071 — 161,071 Government securities — 79,646 — 79,646 Corporate debt securities — 218,050 — 218,050 Total cash equivalents and marketable securities $ 14,172 $ 480,211 $ — $ 494,383 Cash equivalents and marketable securities have been initially valued at the transaction price and subsequently, at the end of each reporting period, valued utilizing third-party pricing services or other market observable data. The pricing services utilize industry standard valuation models, including both income and market-based approaches, and observable market inputs to determine value. After completing our validation procedures, we did not adjust or override any fair value measurements provided by the pricing services as of September 30, 2019. There have been no changes to the valuation methods during the nine months ended September 30, 2019. We evaluate transfers between levels at the end of each reporting period. There were no transfers between Level 1 and Level 2 during the nine months ended September 30, 2019. We have no financial assets or liabilities that were classified as Level 3 at any point during the nine months ended September 30, 2019. |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | Marketable Securities Our marketable securities are classified as available-for-sale pursuant to ASC 320, Investments – Debt and Equity Securities , and are recorded at fair value, with unrealized gains and losses included as a component of accumulated other comprehensive income (loss) in the condensed consolidated balance sheets and statements of stockholders’ equity and a component of total comprehensive loss in the condensed consolidated statements of comprehensive loss, until realized. Realized gains and losses are included in investment income on a specific-identification basis. There were no material realized gains or losses on marketable securities for the three and nine months ended September 30, 2019 and 2018. Marketable securities at September 30, 2019 consisted of the following (in thousands): Amortized Unrealized Unrealized Fair Current: U.S. Treasuries $ 160,981 $ 122 $ (32) $ 161,071 Government securities 58,093 15 (47) 58,061 Corporate debt securities 150,851 241 (36) 151,056 Non-current: Government securities 21,594 15 (24) 21,585 Corporate debt securities 66,672 347 (25) 66,994 Total marketable securities $ 458,191 $ 740 $ (164) $ 458,767 Marketable securities at December 31, 2018 consisted of the following (in thousands): Amortized Unrealized Unrealized Fair Current: Certificates of deposit $ 960 $ — $ (4) $ 956 U.S. Treasuries 231,101 7 (228) 230,880 Government securities 75,335 — (121) 75,214 Corporate debt securities 208,233 — (483) 207,750 Non-current: U.S. Treasuries 12,202 4 (125) 12,081 Government securities 70,177 10 (188) 69,999 Corporate debt securities 139,082 12 (1,055) 138,039 Total marketable securities $ 737,090 $ 33 $ (2,204) $ 734,919 As of September 30, 2019 and December 31, 2018, we held both current and non-current investments. Investments classified as current have maturities of less than one year. Investments classified as non-current are those that: (i) have a maturity of greater than one year, and (ii) we do not intend to liquidate within the next twelve months, although these funds are available for use and, therefore, are classified as available-for-sale. As of September 30, 2019 and December 31, 2018, we held 68 and 242 debt securities, respectively, that were in an unrealized loss position for less than one year. The aggregate fair value of debt securities in an unrealized loss position at September 30, 2019 and December 31, 2018 was $159.8 million and $639.3 million, respectively. There were no individual securities that were in a significant unrealized loss position as of September 30, 2019 and December 31, 2018. Given our intent and ability to hold such securities until recovery, and the lack of significant change in the credit risk of these investments, we do not consider these marketable securities to be other-than-temporarily impaired as of September 30, 2019 and December 31, 2018. |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2019 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Inventory, which consists of commercial supply of TIBSOVO® (ivosidenib), consists of the following (in thousands): September 30, December 31, Raw materials $ 180 $ — Work-in-process 5,375 788 Finished goods 294 81 Total inventory $ 5,849 $ 869 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Leases | Leases On April 11, 2019, we entered into an agreement to lease approximately 13,000 square feet of office space located at 38 Sidney Street, Cambridge, Massachusetts, or the 38 Sidney Lease, with Thirty-Eight Sidney Street, LLC. The initial term of the 38 Sidney Lease commenced on May 1, 2019 and expires on February 29, 2028. At the end of the lease term, we have the option to extend the 38 Sidney Lease for two consecutive terms of five years at fair market rent at the time of the extension. The 38 Sidney Lease provides us with the right to lease additional space within the 38 Sidney Street building and also includes rent escalation clauses and a tenant improvement allowance of $1.0 million. In connection with the 38 Sidney Lease, we also amended our existing building leases at 88 Sidney Street, Cambridge, Massachusetts and at 64 Sidney Street, Cambridge, Massachusetts to extend the initial terms of those leases by approximately three years through February 29, 2028. The amendments also provide us with the right to lease additional space at the 64 Sidney Street building. Our existing extension options for the 88 Sidney Street building and 64 Sidney Street building continue as set forth in the existing leases for those buildings. Our building leases are comprised of office and laboratory space under non-cancelable operating leases. These lease agreements have remaining lease terms of eight years and contain various clauses for renewal at our option. The renewal options were not included in the calculation of the operating lease assets and the operating lease liabilities as the renewal option is not reasonably certain of being exercised. The lease agreements do not contain residual value guarantees. Operating lease costs for the three and nine months ended September 30, 2019 were $3.8 million and $10.6 million, respectively, and cash paid for amounts included in the measurement of operating lease liabilities for the three and nine months ended September 30, 2019 were $2.2 million and $8.5 million, respectively. We have not entered into any material short-term leases or financing leases as of September 30, 2019. As of September 30, 2019, undiscounted minimum rental commitments under non-cancelable leases, for each of the next five years and total thereafter were as follows (in thousands): Remaining 2019 $ 3,526 2020 14,015 2021 14,380 2022 16,773 2023 18,126 2024 18,660 Thereafter 63,891 $ 149,371 In arriving at the operating lease liabilities as of September 30, 2019, we applied the weighted-average incremental borrowing rate of 5.7% over a weighted-average remaining lease term of 8.4 years. As of September 30, 2019, the following represents the difference between the remaining undiscounted minimum rental commitments under non-cancelable leases and the operating lease liabilities (in thousands): Undiscounted minimum rental commitments $ 149,371 Present value adjustment using incremental borrowing rate (33,977) Operating lease liabilities $ 115,394 As of December 31, 2018, minimum rental commitments under non-cancelable leases, for each of the next five years and total thereafter were as follows (in thousands): 2019 $ 12,759 2020 13,135 2021 13,473 2022 15,552 2023 17,145 Thereafter 19,223 $ 91,287 |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2019 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses consist of the following (in thousands): September 30, December 31, Accrued compensation $ 13,494 $ 20,843 Accrued research and development costs 25,036 14,777 Accrued professional fees 5,144 5,441 Accrued other 3,076 1,086 Total accrued expenses $ 46,750 $ 42,147 |
Product Revenue
Product Revenue | 9 Months Ended |
Sep. 30, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Product Revenue | Product Revenue We sell TIBSOVO®, our wholly owned product, to a limited number of specialty distributors and specialty pharmacy providers in the U.S., or collectively, the Customers. The Customers subsequently resell TIBSOVO® to pharmacies or dispense directly to patients. In addition to distribution agreements with Customers, we enter into arrangements with healthcare providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts with respect to the purchase of TIBSOVO®. The performance obligation related to the sale of TIBSOVO® is satisfied and revenue is recognized when the Customer obtains control of the product, which occurs at a point in time, typically upon delivery to the Customer. Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price, or transaction price, which includes estimates of variable consideration for which reserves are established and result from contractual adjustments, government rebates, returns and other allowances that are offered within the contracts with our Customers, healthcare providers, payors and other indirect customers relating to the sale of our products. Contractual Adjustments We generally provide Customers with discounts, including prompt pay discounts, and allowances that are explicitly stated in the contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, we receive sales order management, data and distribution services from certain Customers. Chargebacks for fees and discounts represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from us. Customers charge us for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are estimated using the expected value method, based upon a range of possible outcomes that are probability-weighted for the estimated channel mix and are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue. Government Rebates Government rebates consist of Medicare, TriCare, and Medicaid rebates, which we estimate using the expected value method, based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue. For Medicare, we also estimate the number of patients in the prescription drug coverage gap for whom we will owe an additional liability under the Medicare Part D program. Returns We estimate the amount of product sales that may be returned by Customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized. We currently estimate product return liabilities using the expected value method, based on available industry data, including our visibility into the inventory remaining in the distribution channel. Total net product revenue from U.S. sales of TIBSOVO®, which is our only source of product revenue, was $17.4 million and $40.3 million for the three and nine months ended September 30, 2019, respectively, and $4.5 million for the three and nine months ended September 30, 2018. The following table summarizes balances and activity in each of the product revenue allowance and reserve categories for the nine months ended September 30, 2019 (in thousands): Contractual Adjustments Government Rebates Returns Total Balance at December 31, 2018 $ 592 $ 325 $ 334 $ 1,251 Current provisions relating to sales in the current year 5,596 1,402 1,003 8,001 Adjustments relating to prior years 8 (48) — (40) Payments/returns relating to sales in the current year (4,583) (714) — (5,297) Payments/returns relating to sales in the prior years (598) (261) — (859) Balance at September 30, 2019 $ 1,015 $ 704 $ 1,337 $ 3,056 Total revenue-related reserves above, included in our condensed consolidated balance sheets, are summarized as follows (in thousands): September 30, December 31, Reduction of accounts receivable $ 549 $ 326 Component of accrued expenses 2,507 925 Total revenue-related reserves $ 3,056 $ 1,251 The following table presents changes in our contract assets during the nine months ended September 30, 2019 (in thousands): December 31, Additions Deductions September 30, Contract assets (1) Accounts receivable, net $ 5,076 $ 48,219 $ (46,189) $ 7,106 |
Collaboration and License Agree
Collaboration and License Agreements | 9 Months Ended |
Sep. 30, 2019 | |
Revenue Recognition and Deferred Revenue [Abstract] | |
Collaboration and License Agreements | Collaboration and License Agreements Accounting analysis and revenue recognition Our collaboration and license agreements typically involve us granting licenses of our intellectual property and performing research and development services in exchange of upfront fees, milestone payments and royalty payments. Since December 31, 2018, there have been no material changes to the key terms of our collaboration or license agreements. For further information on the terms and conditions of our existing collaboration and license agreements, please see the notes to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2018. Collaboration revenue On January 1, 2018 we adopted ASC 606, Revenue from Contracts with Customers, under the modified retrospective method. Prior to January 1, 2018, we accounted for collaboration agreements under ASC 605-25, Multiple Element Arrangements. In determining the appropriate amount of revenue to be recognized under ASC 606, we performed the following steps: (i) identified the promised goods or services in the contract; (ii) determined whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measured the transaction price, including the constraint on variable consideration; (iv) allocated the transaction price to the performance obligations; and (v) recognized revenue when (or as) we satisfied each performance obligation. Royalty revenue For arrangements that include sales-based royalties and sales-based milestones and in which the license is deemed to be the predominant item to which the royalties relate, we recognize royalty revenue upon the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Milestone revenue At each reporting period we evaluate whether milestones are considered probable of being reached and, to the extent that a significant reversal would not occur in future periods, estimate the amount to be included in the transaction price using the most likely amount method. Milestone payments that are not within our control, such as regulatory approvals, are not considered probable of being achieved and are excluded from the transaction price until those approvals are received. Celgene Corporation We have entered into the following collaboration agreements, or collectively, the Collaboration Agreements, with Celgene Corporation, or Celgene, which is a related party through ownership of our common stock: • In April 2010, we entered into a discovery and development collaboration and license agreement focused on cancer metabolism, or the 2010 Agreement, which was amended in October 2011 and July 2014. The discovery phase of the 2010 Agreement expired in April 2016. On August 15, 2016, we terminated the 2010 Agreement as to the program directed to the isocitrate dehydrogenase 1, or IDH1, target, for which ivosidenib was the lead development candidate. Accordingly, the sole program remaining under the 2010 Agreement is IDHIFA® (enasidenib), a co-commercialized licensed program for which Celgene leads and funds global development and commercialization activities. Under the remaining terms of the 2010 Agreement, we are eligible to receive up to $80.0 million in potential milestone payments for the enasidenib program. The potential milestone payments are comprised of: (i) up to $55.0 million in milestone payments upon achievement of specified ex-U.S. regulatory milestone events, and (ii) a $25.0 million milestone payment upon achievement of a specified ex-U.S. commercial milestone event, as well as royalties at tiered, low-double digit to mid-teen percentage rates on net sales of IDHIFA®. • In April 2015, we entered into a joint worldwide development and profit share collaboration and license agreement with Celgene, and our wholly owned subsidiary, Agios International Sarl, entered into a collaboration and license agreement with Celgene International II Sarl, or collectively, the AG-881 Agreements, to establish a worldwide collaboration focused on the development and commercialization of vorasidenib products. Under the AG-881 Agreements, we and Celgene split all worldwide development costs for vorasidenib, subject to specified exceptions. The AG-881 Agreements were terminated effective September 4, 2018, upon which we received sole global rights to vorasidenib. In connection with the termination of the AG-881 Agreements, Celgene will be eligible to receive royalties from us at a low single-digit percentage rate on worldwide net sales of products containing vorasidenib. • In May 2016, we entered into a master research and collaboration agreement with Celgene, or the 2016 Agreement, focused on metabolic immuno-oncology, or MIO. The initial four one Collaboration revenue During the three and nine months ended September 30, 2019 and 2018, we recognized the following collaboration revenue (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Services performed that were considered performance obligations as of the modification dates Licenses $ — $ — $ — $ 15,000 On-going research and development services 4,695 7,504 29,915 23,698 Services performed that were not considered performance obligations as of the modification dates Development activities — 312 — 902 Commercialization activities 821 916 2,499 2,878 Total collaboration revenue - related party $ 5,516 $ 8,732 $ 32,414 $ 42,478 The following table presents changes in our contract assets and liabilities during the nine months ended September 30, 2019 (in thousands): December 31, Additions Deductions September 30, Contract assets (1) Collaboration receivable – related party $ 2,462 $ 6,568 $ (7,192) $ 1,838 Royalty receivable – related party 2,234 7,569 (7,203) 2,600 Contract liabilities (2) Deferred revenue – related party, current and net of current portions 92,519 5,000 (30,849) 66,670 (1) Additions to contract assets relate to amounts billed to Celgene during the reporting period. Deductions to contract assets relate to collection of receivables during the reporting period. (2) Additions to contract liabilities relate to consideration from Celgene during the reporting period. Deductions to contract liabilities relate to deferred revenue recognized as revenue during the reporting period. During the three and nine months ended September 30, 2019 and 2018, we recognized the following as revenue due to changes in the contract liability balances (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Amounts included in the contract liability at the beginning of the period $ 4,404 $ 7,555 $ 28,823 $ 23,472 Performance obligations satisfied in previous periods — 219 — 762 As of September 30, 2019, the aggregate amount of the transaction price allocated to performance obligations that are partially unsatisfied was $70.8 million. This amount is expected to be recognized as performance obligations are satisfied through March 2023. Royalty revenue As the underlying performance obligation, or delivery of the enasidenib license, had been satisfied as of June 2014, royalty revenue is recognized as the related sales occur. During the three and nine months ended September 30, 2019 and 2018, we recognized the following as royalty revenue (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Royalty revenue – related party $ 2,666 $ 2,001 $ 7,569 $ 4,991 Milestone revenue During the three months ended June 30, 2018, Celgene submitted a marketing authorization application, or MAA, to the European Medicines Agency, or EMA, for IDHIFA® for isocitrate dehydrogenase 2, or IDH2, mutant-positive relapsed or refractory, or R/R, acute myeloid leukemia, or AML. As a result of the filing, we recognized a $15.0 million milestone payment as collaboration revenue - related party. No other milestones were achieved during the three and nine months ended September 30, 2019 or 2018. The next potential milestone expected to be achieved under our Collaboration Agreements is the first regulatory approval in any of China, Japan or a major European country, which would result in a milestone payment of $35.0 million under the 2010 Agreement. CStone Pharmaceuticals In June 2018, we and CStone Pharmaceuticals, or CStone, entered into an exclusive license agreement, or the CStone Agreement, to grant CStone specified intellectual property licenses to enable CStone to develop and commercialize certain products containing ivosidenib in mainland China, Hong Kong, Macau and Taiwan, or the CStone Territory. We retain development and commercialization rights for the rest of the world. Pursuant to the CStone Agreement, CStone will initially be responsible for the development and commercialization of ivosidenib in AML, cholangiocarcinoma, and, at our discretion, brain cancer indications. CStone is responsible for all costs it incurs in developing, obtaining regulatory approval of, and commercializing ivosidenib in the CStone Territory, as well as certain costs incurred by us. Pursuant to the CStone Agreement, we received an initial upfront payment in the amount of $12.0 million and are entitled to receive up to an additional $412.0 million in milestone payments upon the achievement of certain development, regulatory and sales milestone events. We will also be entitled to receive tiered royalties, ranging from 15% to 19% percent, on annual net sales, if any, of ivosidenib in the CStone Territory. Collaboration revenue During the three and nine months ended September 30, 2019 and 2018, we recognized the following collaboration revenue -other (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Services performed that were considered performance obligations as of the inception date License and other services $ (103) $ — $ (103) $ 12,440 Services performed that were not considered performance obligations as of the inception date Other Services 523 — 2,305 — Total collaboration revenue - other $ 420 $ — $ 2,202 $ 12,440 The following table presents changes in our contract assets during the nine months ended September 30, 2019 (in thousands): December 31, Additions Deductions September 30, Contract assets (1) Collaboration receivable - other $ 670 $ 2,651 $ (2,452) $ 869 (1) Additions to contract assets relate to amounts receivable from CStone. Deductions to contract assets relate to collection of receivables during the reporting period. As of September 30, 2019, the aggregate amount of the transaction price allocated to performance obligations that are partially unsatisfied was $0.5 million. Royalty revenue The license was determined to be the predominant item to which sales-based royalties and sales-based milestones relate. As the license was delivered in June 2018, we will recognize royalty revenue when the related sales occur. To date, no royalties have been received under the CStone Agreement. Milestone revenue No milestones were earned during the three and nine months ended September 30, 2019 and 2018. The next potential milestone expected to be achieved under the CStone Agreement is the dosing of the first patient in a local study in a hematological indication in mainland China. Achievement of this event will result in a milestone payment of $5.0 million. |
Share-Based Payments
Share-Based Payments | 9 Months Ended |
Sep. 30, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Share-Based Payments | Share-Based Payments 2013 Stock Incentive Plan In June 2013, our Board of Directors adopted and, in July 2013 our stockholders approved, the 2013 Stock Incentive Plan, or the 2013 Plan. The 2013 Plan became effective upon the closing of our initial public offering and provides for the grant of stock options and other stock-based awards. Following the adoption of the 2013 Plan, we granted no further stock options or other stock-based awards under the 2007 Stock Incentive Plan, or the 2007 Plan. Any stock options or stock-based awards outstanding under the 2007 Plan at the time of adoption of the 2013 Plan remained outstanding and effective. As of September 30, 2019, the total number of shares reserved under the 2007 Plan and the 2013 Plan was 9,392,668, and we had 2,248,177 shares available for future issuance under the 2013 Plan. Stock options The following table presents stock option activity for the nine months ended September 30, 2019: Number of Weighted-Average Exercise Price Outstanding at December 31, 2018 5,416,069 $ 60.10 Granted 1,577,686 55.85 Exercised (253,323) 34.51 Forfeited/Expired (554,497) 67.59 Outstanding at September 30, 2019 6,185,935 $ 59.39 Exercisable at September 30, 2019 3,441,309 $ 58.90 Vested and expected to vest at September 30, 2019 6,185,935 $ 59.39 At September 30, 2019, there was approximately $102.3 million of total unrecognized compensation expense related to unvested stock option awards, which we expect to recognize over a weighted-average period of approximately 2.7 years. Restricted stock units The following table presents restricted stock unit, or RSU, activity for the nine months ended September 30, 2019: Number of Weighted-Average Grant Date Fair Value Unvested shares at December 31, 2018 532,144 $ 75.45 Granted 437,227 57.25 Vested (160,703) 69.52 Forfeited (75,568) 71.79 Unvested shares at September 30, 2019 733,100 $ 66.28 As of September 30, 2019, there was approximately $32.1 million of total unrecognized compensation expense related to RSUs, which we expect to recognize over a weighted-average period of approximately 1.8 years. Performance-based stock units The following table presents performance-based stock unit, or PSU, activity for the nine months ended September 30, 2019: Number of Weighted-Average Grant Date Fair Value Unvested shares at December 31, 2018 169,031 $ 52.67 Granted 180,761 58.64 Vested (167,031) 52.36 Unvested shares at September 30, 2019 182,761 $ 58.87 Stock-based compensation expense associated with these PSUs is recognized if the underlying performance condition is considered probable of achievement using our management’s best estimates. As of September 30, 2019, there was approximately $2.0 million of total unrecognized compensation expense related to PSUs with performance-based vesting criteria that are considered probable of achievement, which we expect to recognize over a weighted-average period of 0.6 years, and $7.2 million of total unrecognized compensation expense related to PSUs with performance-based vesting criteria that are considered not probable of achievement. Market-based stock units The following table presents market-based stock unit, or MSU, activity for the nine months ended September 30, 2019: Number of Weighted-Average Unvested shares at December 31, 2018 — $ — Granted 42,695 41.50 Unvested shares at September 30, 2019 42,695 $ 41.50 The fair value of MSUs are estimated using a Monte Carlo simulation model. Assumptions and estimates utilized in the model include the risk-free interest rate, dividend yield, expected stock volatility and the estimated period to achievement of the market condition. As of September 30, 2019, there was approximately $1.1 million of total unrecognized compensation expense related to MSUs, which we expect to recognize over the remaining derived service period of 1.0 year. 2013 Employee Stock Purchase Plan In June 2013, our Board of Directors adopted, and in July 2013 our stockholders approved, the 2013 Employee Stock Purchase Plan, or the 2013 ESPP. We issued 77,981 and 53,255 shares of common stock during the nine months ended September 30, 2019 and 2018, respectively, under the 2013 ESPP. The 2013 ESPP provides participating employees with the opportunity to purchase up to an aggregate of 327,272 shares of our common stock. As of September 30, 2019, we had 82,555 shares of common stock available for future issuance under the 2013 ESPP. Stock-based compensation expense Stock-based compensation expense by award type included within the condensed consolidated statements of operations is as follows (in thousands): Three Months Ended Nine Months Ended 2019 2018 2019 2018 Stock options $ 11,552 $ 12,953 $ 37,065 $ 38,736 Restricted stock units 4,917 3,338 14,708 7,940 Employee stock purchase plan 350 246 1,070 838 Other stock awards 1,769 7,656 2,400 7,656 Total stock-based compensation expense $ 18,588 $ 24,193 $ 55,243 $ 55,170 Expenses related to stock options and stock-based awards were allocated as follows in the condensed consolidated statements of operations (in thousands): Three Months Ended Nine Months Ended 2019 2018 2019 2018 Research and development expense $ 9,860 $ 13,399 $ 29,969 $ 31,706 Selling, general and administrative expense 8,728 10,794 25,274 23,464 Total stock-based compensation expense $ 18,588 $ 24,193 $ 55,243 $ 55,170 |
Loss per Share
Loss per Share | 9 Months Ended |
Sep. 30, 2019 | |
Earnings Per Share [Abstract] | |
Loss per Share | Loss per ShareBasic net loss per share is calculated by dividing net loss by the weighted-average shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury stock method. For purposes of the dilutive net loss per share calculation, stock options, RSUs, PSUs and MSUs for which the performance and market vesting conditions, respectively, have been met, and 2013 ESPP shares are considered to be common stock equivalents, while PSUs and MSUs with performance and market vesting conditions, respectively, that were not met as of September 30, 2019 are not considered to be common stock equivalents. Since we had a net loss for all periods presented, the effect of all potentially dilutive securities is anti-dilutive. Accordingly, basic and diluted net loss per share was the same for all periods presented. The following common stock equivalents were excluded from the calculation of diluted net loss per share applicable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: Three and Nine Months Ended September 30, 2019 2018 Stock options 6,185,935 5,485,314 Restricted stock units 733,100 453,736 Other stock units — 167,031 Employee stock purchase plan 13,754 5,332 Total common stock equivalents 6,932,789 6,111,413 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Basis of presentation | The condensed consolidated balance sheet as of September 30, 2019, the condensed consolidated statements of operations, comprehensive loss and stockholders' equity for the three and nine months ended September 30, 2019 and 2018, and the condensed consolidated statements of cash flows for the nine months ended September 30, 2019 and 2018 are unaudited. The unaudited condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of our management, reflect all adjustments, which include only normal recurring adjustments, necessary to fairly state our financial position as of September 30, 2019, our results of operations and stockholders' equity for the three and nine months ended September 30, 2019 and 2018, and cash flows for the nine months ended September 30, 2019 and 2018. The financial data and the other financial information disclosed in these notes to the condensed consolidated financial statements related to the three and nine-month periods are also unaudited. The results of operations for the three and nine months ended September 30, 2019 are not necessarily indicative of the results to be expected for the year ending December 31, 2019 or for any other future annual or interim period. The condensed consolidated balance sheet data as of December 31, 2018 was derived from our audited financial statements, but does not include all disclosures required by U.S. generally accepted accounting principles, or U.S. GAAP. Accordingly, the condensed consolidated interim financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2018 that was filed with the Securities and Exchange Commission, or the SEC, on February 14, 2019. Our condensed consolidated financial statements include our accounts and the accounts of our wholly owned subsidiaries. All intercompany transactions have been eliminated in consolidation. The condensed consolidated financial statements have been prepared in conformity with U.S. GAAP. |
Leases | In February 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2016-02, Leases (Topic 842) , which was codified as Accounting Standards Codification, or ASC, 842, Leases , and amended through subsequent ASUs. We adopted ASC 842 effective January 1, 2019 using the modified retrospective transition approach and elected the package of practical expedients, both provided for under ASU 2018-11, Leases (Topic 842): Targeted Improvements . The package of practical expedients allows us not to reassess whether contracts are or contain leases, lease classification, and whether initial direct costs qualify for capitalization. Additionally, as an accounting policy, we have chosen not to separate the non-lease components from the lease components for our building leases and, instead, accounted for non-lease and lease components as a single component. Impact of Adoption of ASC 842 Upon adoption of ASC 842 on January 1, 2019, we recorded operating lease assets of $59.9 million and operating lease liabilities of $77.3 million. The adoption of ASC 842 did not have a material impact on our condensed consolidated statements of operations. Prior periods are presented in accordance with ASC 840, Leases . Leases Accounting Policy We determine if an arrangement is a lease at inception. An arrangement is determined to contain a lease if the contract conveys the right to control the use of an identified property, plant, or equipment for a period of time in exchange for consideration. If we can benefit from the various underlying assets of a lease on their own or together with other resources that are readily available, or if the various underlying assets are neither highly dependent on nor highly interrelated with other underlying assets in the arrangement, they are considered to be a separate lease component. In the event multiple underlying assets are identified, the lease consideration is allocated to the various components based on each of the component’s relative fair value. Operating lease assets represent our right to use an underlying asset for the lease term and operating lease liabilities represent our obligation to make lease payments arising from the leasing arrangement. Operating lease assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As most of our leases do not provide an implicit rate, in determining the operating lease liabilities we use an estimate of our incremental borrowing rate. The incremental borrowing rate is determined using two alternative credit scoring models to estimate our credit rating, adjusted for collateralization. The calculation of the operating lease assets includes any lease payments made and excludes any lease incentives. Our lease terms may include options to extend or terminate the lease when it is reasonably certain that we will exercise that option. For operating leases, we record operating lease assets and liabilities in our consolidated balance sheets. Lease expense for lease payments is recognized on a straight-line basis over the lease term. Short-term leases, or leases that have a lease term of 12 months or less at commencement date, are excluded from this treatment and are recognized on a straight-line basis over the term of the lease. |
Recent accounting pronouncements | Other accounting standards that have been issued by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on our financial statements upon adoption. |
Fair Value Measurements | We record cash equivalents and marketable securities at fair value. ASC 820, Fair Value Measurements and Disclosures , establishes a fair value hierarchy for those instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and our own assumptions (unobservable inputs). The hierarchy consists of three levels: Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities. Level 2 – Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, directly or indirectly, for substantially the full term of the asset or liability. Level 3 – Unobservable inputs that reflect our own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date. |
Marketable Securities | Our marketable securities are classified as available-for-sale pursuant to ASC 320, Investments – Debt and Equity Securities |
Product Revenue | The performance obligation related to the sale of TIBSOVO® is satisfied and revenue is recognized when the Customer obtains control of the product, which occurs at a point in time, typically upon delivery to the Customer. Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price, or transaction price, which includes estimates of variable consideration for which reserves are established and result from contractual adjustments, government rebates, returns and other allowances that are offered within the contracts with our Customers, healthcare providers, payors and other indirect customers relating to the sale of our products. Contractual Adjustments We generally provide Customers with discounts, including prompt pay discounts, and allowances that are explicitly stated in the contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, we receive sales order management, data and distribution services from certain Customers. Chargebacks for fees and discounts represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from us. Customers charge us for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are estimated using the expected value method, based upon a range of possible outcomes that are probability-weighted for the estimated channel mix and are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue. Government Rebates Government rebates consist of Medicare, TriCare, and Medicaid rebates, which we estimate using the expected value method, based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue. For Medicare, we also estimate the number of patients in the prescription drug coverage gap for whom we will owe an additional liability under the Medicare Part D program. Returns We estimate the amount of product sales that may be returned by Customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized. We currently estimate product return liabilities using the expected value method, based on available industry data, including our visibility into the inventory remaining in the distribution channel. |
Loss per Share | Basic net loss per share is calculated by dividing net loss by the weighted-average shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury stock method. For purposes of the dilutive net loss per share calculation, stock options, RSUs, PSUs and MSUs for which the performance and market vesting conditions, respectively, have been met, and 2013 ESPP shares are considered to be common stock equivalents, while PSUs and MSUs with performance and market vesting conditions, respectively, that were not met as of September 30, 2019 are not considered to be common stock equivalents. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Cash Equivalents and Marketable Securities Measured at Fair Value on a Recurring Basis | The following table summarizes our cash equivalents and marketable securities measured at fair value on a recurring basis as of September 30, 2019 (in thousands): Level 1 Level 2 Level 3 Total Cash equivalents $ 14,172 $ 21,444 $ — $ 35,616 Marketable securities: U.S. Treasuries — 161,071 — 161,071 Government securities — 79,646 — 79,646 Corporate debt securities — 218,050 — 218,050 Total cash equivalents and marketable securities $ 14,172 $ 480,211 $ — $ 494,383 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Marketable Securities | Marketable securities at September 30, 2019 consisted of the following (in thousands): Amortized Unrealized Unrealized Fair Current: U.S. Treasuries $ 160,981 $ 122 $ (32) $ 161,071 Government securities 58,093 15 (47) 58,061 Corporate debt securities 150,851 241 (36) 151,056 Non-current: Government securities 21,594 15 (24) 21,585 Corporate debt securities 66,672 347 (25) 66,994 Total marketable securities $ 458,191 $ 740 $ (164) $ 458,767 Marketable securities at December 31, 2018 consisted of the following (in thousands): Amortized Unrealized Unrealized Fair Current: Certificates of deposit $ 960 $ — $ (4) $ 956 U.S. Treasuries 231,101 7 (228) 230,880 Government securities 75,335 — (121) 75,214 Corporate debt securities 208,233 — (483) 207,750 Non-current: U.S. Treasuries 12,202 4 (125) 12,081 Government securities 70,177 10 (188) 69,999 Corporate debt securities 139,082 12 (1,055) 138,039 Total marketable securities $ 737,090 $ 33 $ (2,204) $ 734,919 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory, which consists of commercial supply of TIBSOVO® (ivosidenib), consists of the following (in thousands): September 30, December 31, Raw materials $ 180 $ — Work-in-process 5,375 788 Finished goods 294 81 Total inventory $ 5,849 $ 869 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Schedule of Undiscounted Minimum Rental Commitments Under Topic 842 | As of September 30, 2019, undiscounted minimum rental commitments under non-cancelable leases, for each of the next five years and total thereafter were as follows (in thousands): Remaining 2019 $ 3,526 2020 14,015 2021 14,380 2022 16,773 2023 18,126 2024 18,660 Thereafter 63,891 $ 149,371 |
Schedule of Difference Between Remaining Undiscounted Minimum Rental Commitments and Lease Liability | As of September 30, 2019, the following represents the difference between the remaining undiscounted minimum rental commitments under non-cancelable leases and the operating lease liabilities (in thousands): Undiscounted minimum rental commitments $ 149,371 Present value adjustment using incremental borrowing rate (33,977) Operating lease liabilities $ 115,394 |
Schedule of Undiscounted Minimum Rental Commitments Under Topic 840 | As of December 31, 2018, minimum rental commitments under non-cancelable leases, for each of the next five years and total thereafter were as follows (in thousands): 2019 $ 12,759 2020 13,135 2021 13,473 2022 15,552 2023 17,145 Thereafter 19,223 $ 91,287 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consist of the following (in thousands): September 30, December 31, Accrued compensation $ 13,494 $ 20,843 Accrued research and development costs 25,036 14,777 Accrued professional fees 5,144 5,441 Accrued other 3,076 1,086 Total accrued expenses $ 46,750 $ 42,147 |
Product Revenue (Tables)
Product Revenue (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Product Revenue Allowance and Reserves | The following table summarizes balances and activity in each of the product revenue allowance and reserve categories for the nine months ended September 30, 2019 (in thousands): Contractual Adjustments Government Rebates Returns Total Balance at December 31, 2018 $ 592 $ 325 $ 334 $ 1,251 Current provisions relating to sales in the current year 5,596 1,402 1,003 8,001 Adjustments relating to prior years 8 (48) — (40) Payments/returns relating to sales in the current year (4,583) (714) — (5,297) Payments/returns relating to sales in the prior years (598) (261) — (859) Balance at September 30, 2019 $ 1,015 $ 704 $ 1,337 $ 3,056 |
Schedule of Revenue Related Reserves | Total revenue-related reserves above, included in our condensed consolidated balance sheets, are summarized as follows (in thousands): September 30, December 31, Reduction of accounts receivable $ 549 $ 326 Component of accrued expenses 2,507 925 Total revenue-related reserves $ 3,056 $ 1,251 |
Schedule of Changes in Contract Assets and Liabilities, Product Revenue | The following table presents changes in our contract assets during the nine months ended September 30, 2019 (in thousands): December 31, Additions Deductions September 30, Contract assets (1) Accounts receivable, net $ 5,076 $ 48,219 $ (46,189) $ 7,106 |
Collaboration and License Agr_2
Collaboration and License Agreements (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Revenue Recognition and Deferred Revenue [Abstract] | |
Schedule of Collaboration Revenue | During the three and nine months ended September 30, 2019 and 2018, we recognized the following collaboration revenue (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Services performed that were considered performance obligations as of the modification dates Licenses $ — $ — $ — $ 15,000 On-going research and development services 4,695 7,504 29,915 23,698 Services performed that were not considered performance obligations as of the modification dates Development activities — 312 — 902 Commercialization activities 821 916 2,499 2,878 Total collaboration revenue - related party $ 5,516 $ 8,732 $ 32,414 $ 42,478 |
Schedule of Changes in Contract Assets and Liabilities | The following table presents changes in our contract assets and liabilities during the nine months ended September 30, 2019 (in thousands): December 31, Additions Deductions September 30, Contract assets (1) Collaboration receivable – related party $ 2,462 $ 6,568 $ (7,192) $ 1,838 Royalty receivable – related party 2,234 7,569 (7,203) 2,600 Contract liabilities (2) Deferred revenue – related party, current and net of current portions 92,519 5,000 (30,849) 66,670 (1) Additions to contract assets relate to amounts billed to Celgene during the reporting period. Deductions to contract assets relate to collection of receivables during the reporting period. (2) Additions to contract liabilities relate to consideration from Celgene during the reporting period. Deductions to contract liabilities relate to deferred revenue recognized as revenue during the reporting period. During the three and nine months ended September 30, 2019 and 2018, we recognized the following as revenue due to changes in the contract liability balances (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Amounts included in the contract liability at the beginning of the period $ 4,404 $ 7,555 $ 28,823 $ 23,472 Performance obligations satisfied in previous periods — 219 — 762 |
Schedule of Royalty Revenue | During the three and nine months ended September 30, 2019 and 2018, we recognized the following as royalty revenue (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Royalty revenue – related party $ 2,666 $ 2,001 $ 7,569 $ 4,991 |
Schedule of Collaboration Revenue Under CStone Agreement | During the three and nine months ended September 30, 2019 and 2018, we recognized the following collaboration revenue -other (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Services performed that were considered performance obligations as of the inception date License and other services $ (103) $ — $ (103) $ 12,440 Services performed that were not considered performance obligations as of the inception date Other Services 523 — 2,305 — Total collaboration revenue - other $ 420 $ — $ 2,202 $ 12,440 |
Schedule of Changes in Contract Assets and Liabilities, CStone Agreement | The following table presents changes in our contract assets during the nine months ended September 30, 2019 (in thousands): December 31, Additions Deductions September 30, Contract assets (1) Collaboration receivable - other $ 670 $ 2,651 $ (2,452) $ 869 (1) Additions to contract assets relate to amounts receivable from CStone. Deductions to contract assets relate to collection of receivables during the reporting period. |
Share-Based Payments (Tables)
Share-Based Payments (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Company's Stock Option Activity | The following table presents stock option activity for the nine months ended September 30, 2019: Number of Weighted-Average Exercise Price Outstanding at December 31, 2018 5,416,069 $ 60.10 Granted 1,577,686 55.85 Exercised (253,323) 34.51 Forfeited/Expired (554,497) 67.59 Outstanding at September 30, 2019 6,185,935 $ 59.39 Exercisable at September 30, 2019 3,441,309 $ 58.90 Vested and expected to vest at September 30, 2019 6,185,935 $ 59.39 |
Unvested Stock Unit Activity | The following table presents restricted stock unit, or RSU, activity for the nine months ended September 30, 2019: Number of Weighted-Average Grant Date Fair Value Unvested shares at December 31, 2018 532,144 $ 75.45 Granted 437,227 57.25 Vested (160,703) 69.52 Forfeited (75,568) 71.79 Unvested shares at September 30, 2019 733,100 $ 66.28 |
Schedule of Performance-Based Units | The following table presents performance-based stock unit, or PSU, activity for the nine months ended September 30, 2019: Number of Weighted-Average Grant Date Fair Value Unvested shares at December 31, 2018 169,031 $ 52.67 Granted 180,761 58.64 Vested (167,031) 52.36 Unvested shares at September 30, 2019 182,761 $ 58.87 |
Schedule of Market-Based Units Activity | The following table presents market-based stock unit, or MSU, activity for the nine months ended September 30, 2019: Number of Weighted-Average Unvested shares at December 31, 2018 — $ — Granted 42,695 41.50 Unvested shares at September 30, 2019 42,695 $ 41.50 |
Schedule of Stock-Based Compensation Expense by Award Type Included Within the Condensed Consolidated Statements of Operations | Stock-based compensation expense by award type included within the condensed consolidated statements of operations is as follows (in thousands): Three Months Ended Nine Months Ended 2019 2018 2019 2018 Stock options $ 11,552 $ 12,953 $ 37,065 $ 38,736 Restricted stock units 4,917 3,338 14,708 7,940 Employee stock purchase plan 350 246 1,070 838 Other stock awards 1,769 7,656 2,400 7,656 Total stock-based compensation expense $ 18,588 $ 24,193 $ 55,243 $ 55,170 |
Schedule of Allocated Stock-Based Compensation Expense | Expenses related to stock options and stock-based awards were allocated as follows in the condensed consolidated statements of operations (in thousands): Three Months Ended Nine Months Ended 2019 2018 2019 2018 Research and development expense $ 9,860 $ 13,399 $ 29,969 $ 31,706 Selling, general and administrative expense 8,728 10,794 25,274 23,464 Total stock-based compensation expense $ 18,588 $ 24,193 $ 55,243 $ 55,170 |
Loss per Share (Tables)
Loss per Share (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Earnings Per Share [Abstract] | |
Common Stock Excluded from Calculation of Diluted Earnings Per Share | The following common stock equivalents were excluded from the calculation of diluted net loss per share applicable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: Three and Nine Months Ended September 30, 2019 2018 Stock options 6,185,935 5,485,314 Restricted stock units 733,100 453,736 Other stock units — 167,031 Employee stock purchase plan 13,754 5,332 Total common stock equivalents 6,932,789 6,111,413 |
Overview and Basis of Present_2
Overview and Basis of Presentation - Additional Information (Details) $ in Millions | Sep. 30, 2019USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Cash, cash equivalents, and short-term investments | $ 540.5 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Jan. 01, 2019 |
Schedule of Significant Accounting Policies [Line Items] | ||
Operating lease assets | $ 95,833 | |
Operating lease liabilities | $ 115,394 | |
ASU 2016-02 | ||
Schedule of Significant Accounting Policies [Line Items] | ||
Operating lease assets | $ 59,900 | |
Operating lease liabilities | $ 77,300 |
Fair Value Measurements - Cash
Fair Value Measurements - Cash Equivalents and Marketable Securities Measured at Fair Value on a Recurring Basis (Details) - Fair Value, Measurements, Recurring $ in Thousands | Sep. 30, 2019USD ($) |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Cash equivalents | $ 35,616 |
Total cash equivalents and marketable securities | 494,383 |
U.S. Treasuries | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 161,071 |
Government securities | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 79,646 |
Corporate debt securities | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 218,050 |
Level 1 | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Cash equivalents | 14,172 |
Total cash equivalents and marketable securities | 14,172 |
Level 1 | U.S. Treasuries | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 0 |
Level 1 | Government securities | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 0 |
Level 1 | Corporate debt securities | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 0 |
Level 2 | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Cash equivalents | 21,444 |
Total cash equivalents and marketable securities | 480,211 |
Level 2 | U.S. Treasuries | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 161,071 |
Level 2 | Government securities | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 79,646 |
Level 2 | Corporate debt securities | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 218,050 |
Level 3 | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Cash equivalents | 0 |
Total cash equivalents and marketable securities | 0 |
Level 3 | U.S. Treasuries | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 0 |
Level 3 | Government securities | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | 0 |
Level 3 | Corporate debt securities | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Marketable securities | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | Sep. 30, 2019USD ($) |
Fair Value, Measurements, Recurring | Level 3 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Fair value of assets (liabilities) | $ 0 |
Marketable Securities - Additio
Marketable Securities - Additional Information (Details) $ in Millions | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2019USD ($)security | Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($)security | Sep. 30, 2018USD ($) | Dec. 31, 2018USD ($)security | |
Investments, Debt and Equity Securities [Abstract] | |||||
Realized gain (loss) on marketable securities | $ 0 | $ 0 | $ 0 | $ 0 | |
Debt securities in an unrealized loss position | security | 68 | 68 | 242 | ||
Aggregate fair value of debt securities in an unrealized loss position | $ 159.8 | $ 159.8 | $ 639.3 |
Marketable Securities - Summary
Marketable Securities - Summary of Marketable Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 458,191 | $ 737,090 |
Unrealized Gains | 740 | 33 |
Unrealized Losses | (164) | (2,204) |
Fair Value | 458,767 | 734,919 |
Current | Certificates of deposit | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 960 | |
Unrealized Gains | 0 | |
Unrealized Losses | (4) | |
Fair Value | 956 | |
Current | U.S. Treasuries | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 160,981 | 231,101 |
Unrealized Gains | 122 | 7 |
Unrealized Losses | (32) | (228) |
Fair Value | 161,071 | 230,880 |
Current | Government securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 58,093 | 75,335 |
Unrealized Gains | 15 | 0 |
Unrealized Losses | (47) | (121) |
Fair Value | 58,061 | 75,214 |
Current | Corporate debt securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 150,851 | 208,233 |
Unrealized Gains | 241 | 0 |
Unrealized Losses | (36) | (483) |
Fair Value | 151,056 | 207,750 |
Non-current | U.S. Treasuries | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 12,202 | |
Unrealized Gains | 4 | |
Unrealized Losses | (125) | |
Fair Value | 12,081 | |
Non-current | Government securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 21,594 | 70,177 |
Unrealized Gains | 15 | 10 |
Unrealized Losses | (24) | (188) |
Fair Value | 21,585 | 69,999 |
Non-current | Corporate debt securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 66,672 | 139,082 |
Unrealized Gains | 347 | 12 |
Unrealized Losses | (25) | (1,055) |
Fair Value | $ 66,994 | $ 138,039 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 180 | $ 0 |
Work-in-process | 5,375 | 788 |
Finished goods | 294 | 81 |
Total inventory | $ 5,849 | $ 869 |
Leases - Additional Information
Leases - Additional Information (Details) ft² in Thousands, $ in Millions | Apr. 11, 2019USD ($)ft²lease_term | Sep. 30, 2019USD ($) | Sep. 30, 2019USD ($) |
Lessee, Lease, Description [Line Items] | |||
Remaining lease terms | 8 years | ||
Operating lease cost | $ 3.8 | $ 10.6 | |
Cash paid for amounts included in measurement of lease liabilities | $ 2.2 | $ 8.5 | |
Weighted-average incremental borrowing rate | 5.70% | 5.70% | |
Weighted-average remaining lease term | 8 years 4 months 24 days | 8 years 4 months 24 days | |
38 Sidney Street Lease | |||
Lessee, Lease, Description [Line Items] | |||
Number of square feet of office space (in square feet) | ft² | 13 | ||
Number of optional terms available at end of current lease term (in lease terms) | lease_term | 2 | ||
Term of optional lease (in years) | 5 years | ||
Tenant improvement allowance | $ 1 | ||
64 Sidney Street Lease | |||
Lessee, Lease, Description [Line Items] | |||
Term for extension of operating lease (in years) | 3 years |
Leases - Schedule of Undiscount
Leases - Schedule of Undiscounted Minimum Rental Commitments Under Topic 842 (Details) $ in Thousands | Sep. 30, 2019USD ($) |
Leases [Abstract] | |
Remaining 2019 | $ 3,526 |
2020 | 14,015 |
2021 | 14,380 |
2022 | 16,773 |
2023 | 18,126 |
2024 | 18,660 |
Thereafter | 63,891 |
Undiscounted minimum rental commitments | $ 149,371 |
Leases - Difference Between Rem
Leases - Difference Between Remaining Undiscounted Minimum Rental Commitments and Lease Liability (Details) $ in Thousands | Sep. 30, 2019USD ($) |
Leases [Abstract] | |
Undiscounted minimum rental commitments | $ 149,371 |
Present value adjustment using incremental borrowing rate | (33,977) |
Operating lease liabilities | $ 115,394 |
Leases - Schedule of Minimum Re
Leases - Schedule of Minimum Rental Commitments Under Topic 840 (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Leases [Abstract] | |
2019 | $ 12,759 |
2020 | 13,135 |
2021 | 13,473 |
2022 | 15,552 |
2023 | 17,145 |
Thereafter | 19,223 |
Total minimum rental commitments due under non-cancelable leases | $ 91,287 |
Accrued Expenses - Summary of A
Accrued Expenses - Summary of Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Payables and Accruals [Abstract] | ||
Accrued compensation | $ 13,494 | $ 20,843 |
Accrued research and development costs | 25,036 | 14,777 |
Accrued professional fees | 5,144 | 5,441 |
Accrued other | 3,076 | 1,086 |
Total accrued expenses | $ 46,750 | $ 42,147 |
Product Revenue - Additional In
Product Revenue - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 26,024 | $ 15,198 | $ 82,472 | $ 64,374 |
Product revenue, net | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 17,422 | $ 4,465 | $ 40,287 | $ 4,465 |
Product Revenue - Schedule of P
Product Revenue - Schedule of Product Revenue Allowance and Reserves (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | |
Contractual Adjustments [Roll Forward] | ||
Contract adjustments, beginning balance | $ 592 | |
Contractual adjustments, current provisions relating to sales in the current year | 5,596 | |
Contractual adjustments, adjustments relating to prior year | 8 | |
Contractual adjustments, payments/returns relating to sales in the current year | (4,583) | |
Contractual adjustments, payments/returns relating to sales in the prior year | (598) | |
Contract adjustments, ending balance | 1,015 | |
Government Rebates [Roll Forward] | ||
Government rebates, beginning balance | 325 | |
Government rebates, current provisions relating to sales in the current year | 1,402 | |
Government rebates, adjustments relating to prior years | (48) | |
Government rebates, payments/returns relating to sales in the current year | (714) | |
Government rebates, payments/returns relating to sales in the prior years | (261) | |
Government rebates, ending balance | 704 | |
Product Returns [Roll Forward] | ||
Returns, beginning balance | 334 | |
Returns, current provisions relating to sales in the current year | 1,003 | |
Returns, adjustments relating to prior years | 0 | |
Returns, payments/returns relating to sales in the current year | 0 | |
Returns, payments/returns relating to sales in the prior years | 0 | |
Returns, ending balance | 1,337 | |
Allowance for Doubtful Accounts Receivable [Roll Forward] | ||
Total revenue-related reserves | 3,056 | $ 1,251 |
Total allowances and reserves, current provisions relating to sales in the current year | 8,001 | |
Total allowances and reserves, adjustments relating to prior years | (40) | |
Total allowances and reserves, payments/returns relating to sales in the current year | (5,297) | |
Total allowances and reserves, payments/returns relating to sales in the prior years | $ (859) |
Product Revenue - Schedule of R
Product Revenue - Schedule of Revenue-Related Reserves (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Revenue from Contract with Customer [Abstract] | ||
Reduction of accounts receivable | $ 549 | $ 326 |
Component of accrued expenses | 2,507 | 925 |
Total revenue-related reserves | $ 3,056 | $ 1,251 |
Product Revenue - Schedule of C
Product Revenue - Schedule of Changes in Contract Assets and Liabilities, Product Revenue (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2019USD ($) | |
Contract assets | |
Contract assets, beginning balance | $ 5,076 |
Additions | 48,219 |
Deductions | (46,189) |
Contract assets, ending balance | $ 7,106 |
Collaboration and License Agr_3
Collaboration and License Agreements - Celegene Purchase Agreements (Details) | 1 Months Ended | ||
May 31, 2016USD ($)extension | Sep. 30, 2019USD ($) | May 17, 2016USD ($) | |
2010 Agreement | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Milestone-based receivable payments, eligible to be received | $ 80,000,000 | ||
Milestone payments upon achievement of specified regulatory milestone events | 55,000,000 | ||
Milestone payment upon achievement of a specified commercial milestone event | $ 25,000,000 | ||
2016 Agreement | Celgene | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Term of agreements | 4 years | ||
Extension period | extension | 2 | ||
Number of allowable special case extensions | extension | 4 | ||
Special case extension term | 1 year | ||
Upfront payment agreement extension fee receivable | $ 40,000,000 | ||
Option exercise fee receivable | $ 30,000,000 | ||
2016 Agreement | Celgene | Specified clinical development event | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Milestone-based receivable payments, eligible to be received | 20,000,000 | ||
2016 Agreement | Celgene | Maximum | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Milestone-based receivable payments, eligible to be received | 168,800,000 | ||
2016 Agreement | Celgene | Maximum | Specified regulatory milestone events | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Milestone-based receivable payments, eligible to be received | $ 148,800,000 |
Collaboration and License Agr_4
Collaboration and License Agreements - Collaboration Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 26,024 | $ 15,198 | $ 82,472 | $ 64,374 |
Licenses | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 0 | 0 | 0 | 15,000 |
On-going research and development services | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 4,695 | 7,504 | 29,915 | 23,698 |
Development activities | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 0 | 312 | 0 | 902 |
Commercialization activities | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 821 | 916 | 2,499 | 2,878 |
Collaboration revenue – related party | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 5,516 | $ 8,732 | $ 32,414 | $ 42,478 |
Collaboration and License Agr_5
Collaboration and License Agreements - Schedule of Changes in Contract Assets and Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Contract assets | ||||
Contract assets, beginning balance | $ 5,076 | |||
Additions | 48,219 | |||
Deductions | (46,189) | |||
Contract assets, ending balance | $ 7,106 | 7,106 | ||
Contract liabilities | ||||
Additions | 4,404 | $ 7,555 | 28,823 | $ 23,472 |
Collaboration receivable – related party | ||||
Contract assets | ||||
Contract assets, beginning balance | 2,462 | |||
Additions | 6,568 | |||
Deductions | (7,192) | |||
Contract assets, ending balance | 1,838 | 1,838 | ||
Royalty receivable – related party | ||||
Contract assets | ||||
Contract assets, beginning balance | 2,234 | |||
Additions | 7,569 | |||
Deductions | (7,203) | |||
Contract assets, ending balance | 2,600 | 2,600 | ||
Deferred revenue – related party, current and net of current portions | ||||
Contract liabilities | ||||
Contract liabilities, beginning balance | 92,519 | |||
Additions | 5,000 | |||
Deductions | (30,849) | |||
Contract liabilities, ending balance | $ 66,670 | $ 66,670 |
Collaboration and License Agr_6
Collaboration and License Agreements - Schedule of Revenues as a Result of Changes in Contract Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Revenue Recognition and Deferred Revenue [Abstract] | ||||
Amounts included in the contract liability at the beginning of the period | $ 4,404 | $ 7,555 | $ 28,823 | $ 23,472 |
Performance obligations satisfied in previous periods | $ 0 | $ 219 | $ 0 | $ 762 |
Collaboration and License Agr_7
Collaboration and License Agreements - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Remaining unsatisfied performance obligation | $ 70,800,000 | $ 70,800,000 | |||
Milestones achieved | 0 | $ 0 | 0 | $ 0 | |
2010 Agreement | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Potential milestone payment | $ 35,000,000 | $ 35,000,000 | |||
Collaboration revenue – related party | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Milestones achieved | $ 15,000,000 |
Collaboration and License Agr_8
Collaboration and License Agreements - CStone Pharmaceuticals Purchase Agreement (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Jun. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Remaining unsatisfied performance obligation | $ 70,800,000 | $ 70,800,000 | ||||
Revenue | 26,024,000 | $ 15,198,000 | 82,472,000 | $ 64,374,000 | ||
Milestones achieved | 0 | 0 | 0 | 0 | ||
Collaboration revenue – related party | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Revenue | 5,516,000 | 8,732,000 | 32,414,000 | 42,478,000 | ||
Milestones achieved | $ 15,000,000 | |||||
Royalty revenue – related party | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Revenue | 2,666,000 | $ 2,001,000 | 7,569,000 | $ 4,991,000 | ||
CStone Pharmaceuticals | CStone Agreement | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Initial payment received | $ 12,000,000 | |||||
Potential future milestone payments | 5,000,000 | 5,000,000 | ||||
Remaining unsatisfied performance obligation | 500,000 | 500,000 | ||||
Milestones achieved | 0 | |||||
CStone Pharmaceuticals | CStone Agreement | Minimum | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Royalty percentage | 15.00% | |||||
CStone Pharmaceuticals | CStone Agreement | Maximum | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Potential future milestone payments | $ 412,000,000 | 412,000,000 | ||||
Royalty percentage | 19.00% | |||||
CStone Pharmaceuticals | CStone Agreement | Royalty revenue – related party | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Revenue | $ 0 |
Collaboration and License Agr_9
Collaboration and License Agreements - Schedule of Collaboration Revenue from CStone Agreement (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 26,024 | $ 15,198 | $ 82,472 | $ 64,374 |
License and other services | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 0 | 0 | 0 | 15,000 |
License and other services | CStone Agreement | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | (103) | 0 | (103) | 12,440 |
Other Services | CStone Agreement | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 523 | 0 | 2,305 | 0 |
Collaboration revenue – other | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 420 | 0 | 2,202 | 12,440 |
Collaboration revenue – other | CStone Agreement | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 420 | $ 0 | $ 2,202 | $ 12,440 |
Collaboration and License Ag_10
Collaboration and License Agreements - Changes in Contract Assets and Liabilities Under CStone Agreement (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2019USD ($) | |
Contract assets | |
Contract assets, beginning balance | $ 5,076 |
Deductions | (46,189) |
Contract assets, ending balance | 7,106 |
Collaboration receivable - other | CStone Agreement | |
Contract assets | |
Contract assets, beginning balance | 670 |
Additions | 2,651 |
Deductions | (2,452) |
Contract assets, ending balance | $ 869 |
Share-Based Payments - Addition
Share-Based Payments - Additional Information (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Restricted stock units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation expense for options | $ 32,100 | |
Weighted-average period to recognize compensation expense (in years) | 1 year 9 months 18 days | |
Performance Stock Unit, Probable of Meeting Vesting Criteria | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized stock based compensation expense | $ 2,000 | |
Weighted-average period to recognize compensation expense (in years) | 7 months 6 days | |
Market-Based Stock Units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation expense for options | $ 1,100 | |
Weighted-average period to recognize compensation expense (in years) | 1 year | |
2007 Plan and 2013 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock reserved for issuance (in shares) | 9,392,668 | |
2013 Stock Incentive Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares available for future issuance (in shares) | 2,248,177 | |
Unrecognized compensation expense for options | $ 102,300 | |
Weighted-average period to recognize compensation expense (in years) | 2 years 8 months 12 days | |
2013 Stock Incentive Plan | Performance Stock Unit, Not Probable of Meeting Vesting Criteria | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized stock based compensation expense | $ 7,200 | |
Employee stock purchase plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares available for future issuance (in shares) | 82,555 | |
Shares issued under 2013 ESPP (in shares) | 77,981 | 53,255 |
Opportunity to purchase of common stock (in shares) | 327,272 |
Share-Based Payments - Summary
Share-Based Payments - Summary of Stock Option Activity (Details) - $ / shares | 9 Months Ended |
Sep. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | |
Number of Stock Options, Outstanding, Beginning balance (in shares) | 5,416,069 |
Number of Stock Options, Granted (in shares) | 1,577,686 |
Number of Stock Options, Exercised (in shares) | (253,323) |
Number of Stock Options, Forfeited/Expired (in shares) | (554,497) |
Number of Stock Options, Outstanding, Ending balance (in shares) | 6,185,935 |
Number of Stock Options, Exercisable (in shares) | 3,441,309 |
Number of Stock Options, Vested and expected to vest (in shares) | 6,185,935 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Abstract] | |
Weighted-Average Exercise Price, Outstanding, Beginning balance (in usd per share) | $ 60.10 |
Weighted-Average Exercise Price, Granted (in usd per share) | 55.85 |
Weighted-Average Exercise Price, Exercised (in usd per share) | 34.51 |
Weighted-Average Exercise Price, Forfeited/Expired (in usd per share) | 67.59 |
Weighted-Average Exercise Price, Outstanding, Ending balance (in usd per share) | 59.39 |
Weighted-Average Exercise Price, Exercisable (in usd per share) | 58.90 |
Weighted-Average Exercise Price, Vested and expected to vest (in usd per share) | $ 59.39 |
Share-Based Payments - Summar_2
Share-Based Payments - Summary of Unvested RSUs Activity (Details) - Restricted stock units | 9 Months Ended |
Sep. 30, 2019$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Unvested shares beginning of period (in shares) | shares | 532,144 |
Granted (in shares) | shares | 437,227 |
Vested (in shares) | shares | (160,703) |
Forfeited (in shares) | shares | (75,568) |
Unvested shares end of period (in shares) | shares | 733,100 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |
Weighted-average grant date fair value, Unvested shares beginning of period (in usd per share) | $ / shares | $ 75.45 |
Weighted-average grant date fair value, Granted (in usd per share) | $ / shares | 57.25 |
Weighted-average grant date fair value, Vested (in usd per share) | $ / shares | 69.52 |
Weighted-average grant date fair value, Forfeited (in usd per share) | $ / shares | 71.79 |
Weighted-average grant date fair value, Unvested shares end of period (in usd per share) | $ / shares | $ 66.28 |
Share-Based Payments - Schedule
Share-Based Payments - Schedule of Performance-Based and Market- Based Units (Details) | 9 Months Ended |
Sep. 30, 2019$ / sharesshares | |
Performance-Based Stock Units | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Unvested shares beginning of period (in shares) | shares | 169,031 |
Granted (in shares) | shares | 180,761 |
Vested (in shares) | shares | (167,031) |
Unvested shares end of period (in shares) | shares | 182,761 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |
Weighted-average grant date fair value, Unvested shares beginning of period (in usd per share) | $ / shares | $ 52.67 |
Weighted-average grant date fair value, Granted (in usd per share) | $ / shares | 58.64 |
Weighted-average grant date fair value, Vested (in usd per share) | $ / shares | 52.36 |
Weighted-average grant date fair value, Unvested shares end of period (in usd per share) | $ / shares | $ 58.87 |
Market-Based Stock Units | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Unvested shares beginning of period (in shares) | shares | 0 |
Granted (in shares) | shares | 42,695 |
Unvested shares end of period (in shares) | shares | 42,695 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |
Weighted-average grant date fair value, Unvested shares beginning of period (in usd per share) | $ / shares | $ 0 |
Weighted-average grant date fair value, Granted (in usd per share) | $ / shares | 41.50 |
Weighted-average grant date fair value, Unvested shares end of period (in usd per share) | $ / shares | $ 41.50 |
Share-Based Payments - Schedu_2
Share-Based Payments - Schedule of Stock-Based Compensation Expense by Award Type Included Within the Condensed Consolidated Statements of Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 18,588 | $ 24,193 | $ 55,243 | $ 55,170 |
Stock options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 11,552 | 12,953 | 37,065 | 38,736 |
Restricted stock units | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 4,917 | 3,338 | 14,708 | 7,940 |
Employee stock purchase plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 350 | 246 | 1,070 | 838 |
Other stock awards | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 1,769 | $ 7,656 | $ 2,400 | $ 7,656 |
Share-Based Payments - Expenses
Share-Based Payments - Expenses Related to Equity-Based Awards (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 18,588 | $ 24,193 | $ 55,243 | $ 55,170 |
Research and development expense | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | 9,860 | 13,399 | 29,969 | 31,706 |
Selling, general and administrative expense | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total stock-based compensation expense | $ 8,728 | $ 10,794 | $ 25,274 | $ 23,464 |
Loss per Share - Common Stock E
Loss per Share - Common Stock Excluded from Calculation of Diluted Net Loss Per Share (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total common stock equivalents excluded from computation of earnings per share (in shares) | 6,932,789 | 6,111,413 | 6,932,789 | 6,111,413 |
Stock options | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total common stock equivalents excluded from computation of earnings per share (in shares) | 6,185,935 | 5,485,314 | 6,185,935 | 5,485,314 |
Restricted stock units | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total common stock equivalents excluded from computation of earnings per share (in shares) | 733,100 | 453,736 | 733,100 | 453,736 |
Other stock units | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total common stock equivalents excluded from computation of earnings per share (in shares) | 0 | 167,031 | 0 | 167,031 |
Employee stock purchase plan | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total common stock equivalents excluded from computation of earnings per share (in shares) | 13,754 | 5,332 | 13,754 | 5,332 |
Uncategorized Items - agio-2019
Label | Element | Value |
Accounting Standards Update 2014-09 [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ 39,456,000 |
Accounting Standards Update 2014-09 [Member] | Retained Earnings [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ 39,456,000 |